ID Condoms IDDCSTJ0

GUDID 00761236110238

Premium lubricated Latex Condom

WESTRIDGE LABORATORIES INCORPORATED

Basic male condom, Hevea-latex

• Primary Device ID: 00761236110238
• NIH Device Record Key: 95ddff1d-9960-4bb1-b9e8-6366f6aff9a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ID Condoms
• Version Model Number: ID Studded Condoms (Jar/144)
• Catalog Number: IDDCSTJ0
• Company DUNS: 879057065
• Company Name: WESTRIDGE LABORATORIES INCORPORATED
• Device Count: 144
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 17142599400
• Email: service@westridgelabs.com
• Phone: 17142599400
• Email: service@westridgelabs.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00761236110221 [Unit of Use]
GS1	00761236110238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K910284

FDA Product Code

• HIS: Condom

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-09

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